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A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants (MEDI8897 1b)

18 september 2018 uppdaterad av: MedImmune LLC
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.

Studietyp

Interventionell

Inskrivning (Faktisk)

151

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Chile
      • Santiago, Chile
        • Research Site
      • Valdivia, Chile
        • Research Site
  • Förenta staterna
    • California
      • Anaheim, California, Förenta staterna
        • Research Site
      • Ontario, California, Förenta staterna
        • Research Site
    • New York
      • Syracuse, New York, Förenta staterna
        • Research Site
    • Ohio
      • Cleveland, Ohio, Förenta staterna
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Förenta staterna
        • Research Site
    • Utah
      • Saint George, Utah, Förenta staterna
        • Research Site
    • Wisconsin
      • Marshfield, Wisconsin, Förenta staterna
        • Research Site
  • Sydafrika
      • Cape Town, Sydafrika
        • Research Site
      • East London, Sydafrika
        • Research Site
      • Johannesburg, Sydafrika
        • Research Site
      • Pretoria, Sydafrika
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 1 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Key Inclusion Criteria:

  • Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age
  • Infants who are entering their first RSV season at the time of screening

Key Exclusion Criteria:

  • Gestational age < 32 weeks 0 days and >34 weeks 6 days
  • Meets AAP or other local criteria to receive commercial palivizumab
  • Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
  • Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
  • Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
  • Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Participants will receive placebo intramuscularly.
Läkemedel: Placebo
Participants will receive placebo intramuscularly.
Experimentell: MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
Läkemedel: MEDI8897 10 mg
Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
Experimentell: MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
Läkemedel: MEDI8897 25 mg
Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
Experimentell: MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
Läkemedel: MEDI8897 50 mg
Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tidsram: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Tidsram: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Tidsram: From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)
Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.
From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Maximum Observed Serum Concentration (Cmax) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
The Cmax is the maximum observed serum concentration of MEDI8897.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Terminal Elimination Half Life (t1/2) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Extravascular Clearance (CL/F) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Extravascular Volume of Distribution (Vz/F) of MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose
Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
Tidsram: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose
A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive.
Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose

Samarbetspartners och utredare

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Sponsor

MedImmune LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 januari 2015

Primärt slutförande (Faktisk)

28 september 2016

Avslutad studie (Faktisk)

28 september 2016

Studieregistreringsdatum

Först inskickad

17 oktober 2014

Först inskickad som uppfyllde QC-kriterierna

10 november 2014

Första postat (Uppskatta)

14 november 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D5290C00002

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